AddictionNCT01103531
Exercise to Improve Outcomes of Treatment for Methamphetamine Users
A study testing Aerobic and Resistance Exercise and Educational information about health topics in people with Addiction, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this study is to assess the effects of an aerobic and strength training exercise program (one that increases the need for oxygen and increases muscle) on the treatment outcomes of 150 individuals in treatment for methamphetamine dependence at Cri-Help. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Addiction
- What is being tested?
- Aerobic and Resistance Exercise and Educational information about health topics
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be seeking treatment for their MA dependence;
- Be 18 years of age or older, and 45 or younger for males, 55 or younger for females;
- Meet DSM-IV-TR criteria for MA dependence;
- Have vital signs that are within clinically acceptable normal range, e.g., resting pulse between 50 and 90 /min, blood pressures between 85-150mm Hg systolic and 45-90mm Hg diastolic;
- Have a medical history and physical examination that, in the judgment of the study physician or Principal Investigator, show no clinically significant contraindications for study participation;
- For females, provide negative pregnancy urine tests before randomization (and for the sub-sample, another negative test before the final PET scan at the conclusion of the intervention).
Who cannot join
- Clinically significant heart disease or hypertension; unstable pulmonary or cardiovascular disease that would interfere with participation in exercise regimen
- Neurological or psychiatric disorders as assessed by MINI or clinical interview, such as psychosis, bipolar illness, Tourette's syndrome, major depression, organic brain disease, dementia, or any other neuro-psychiatric disorder that would require ongoing treatment or that would make study compliance difficult;
- Musculoskeletal disease that would prevent participation in exercise regimen
- Baseline ECG showing evidence of cardiac ischemia, arrhythmia, or other clinically significant abnormalities
- Untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease (other than HIV) that requires immediate medical attention;
- Clinically significant abnormalities in hematology and chemistry laboratory tests that may make participation hazardous;
Show all 9Show fewer
- Have HIV and unable to obtain a clearance for participation from his/her AIDS medical care provider;
- Pregnant;
- Any other illness, condition, or use of medications that, in the opinion of the PI and/or the study physician, would preclude safe participation or completion of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aerobic Exercise to Improve Outcomes of Treatment for Methamphetamine Dependence
The purpose of this study is to assess the effects of an aerobic and strength training exercise program (one that increases the need for oxygen and increases muscle) on the treatment outcomes of 150 individuals in treatment for methamphetamine dependence at Cri-Help. The study will determine if a 60-minute exercise program (three times a week) has an effect (good or bad) on the health and drug use of participants as compared to individuals not participating in an exercise program.
Read the detailed description
Participants were recruited to the study using various methods, including word of mouth and IRB-approved flyers posted throughout the treatment facility. Onsite study staff screened MA-dependent clients in a private study office and reviewed the informed consent protocol. After completion of informed consent procedures, participants entered a1-2week screening phase to determine eligibility, consisting of medical history, physical exam, laboratory studies, and ECG. Eligible clients were taken through study baseline assessments to inform randomization to study conditions, either an exercise intervention or health education control, using a computerized urn randomization program that stratified clients to conditions based on gender (male/female) and severity of baseline MA use (higher vs. lower severity). The cut-off point for determining lower severity MA use versus higher severity use was identified using data from previous clinical outcome studies that show the median number of days of MA use ranges from16 to 20 days at treatment entry. Hence, we defined "lower severity" as using MA for 18 or fewer days in the previous month, and "higher severity" as using for 19 or more days in the past month. The study's data management center (DMC) maintained the urn randomization program and the records that linked participant identification numbers to study condition. Study interventions were conducted onsite while participants were enrolled in usual care at the residential treatment facility; cases of early discharge from the facility resulted in premature termination from the study.
Participants randomized to the exercise condition received a structured exercise program 3 times a week for 8 weeks. Exercise sessions consisted of a 5-min warm-up, 30 min of aerobic activity on a treadmill, followed by 15 min of weight training and a 5-min cool-down/stretching period. Each session was monitored by a staff exercise physiologist who guided one to two participants at a time. Using heart rate monitors, the exercise physiologist worked closely with each individual participant on exercise days to increase treadmill speed/slope to maintain a heart rate between 60% and 85% of maximum for 30 minutes. Once a participant was able to complete two sets of 15 repetitions of any given exercise, weight was incrementally increased.
A data collection protocol occurred at baseline, and also weekly during the 8-week study period, at termination of the study period, and at 1-, 3-, and 6-months post treatment from the residential program (approximately 7-10 days following completion of the intervention period). Participants were compensated $40 per data collection session.
- Conditions
- Addiction
- Being tested
- Aerobic and Resistance Exercise, Educational information about health topics
- Keywords
- Methamphetamine, Methamphetamine Dependence, Methamphetamine Treatment, Aerobic Exercise, Resistance Exercise, Brain Imaging, D2 and D3 receptor availability
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic and Resistance ExerciseBehavioural
Aerobic and resistance exercise for 24 exercise training sessions over an 8-week period (three times weekly).
Educational information about health topicsBehavioural
A counselor will meet with participants for 24 sessions (3 times/week) over an 8-week period to present and discuss information that includes topics on health and wellness, and lifestyle topics such as healthy eating, meditation, sleep hygiene, and cancer screening.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Participants in this group will be scheduled for 24 exercise training sessions over an 8-week period (three times weekly) and will be supervised by a certified exercise physiologist. Receives: Behavioral: Aerobic and Resistance Exercise |
| Education Group | Active comparator | Participants in this group will meet with a counselor who will present and discuss information that includes topics on health and wellness, and lifestyle topics such as healthy eating, meditation, sleep hygiene, and cancer screening. Receives: Behavioral: Educational information about health topics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Days of Methamphetamine Use
The primary efficacy measure will be days of self-reported MA use over the 12 weeks after discharge.
Measured: over the 12 week follow-up period
Secondary outcomes (3)
Overall Physical Health
The effect of the interventions will be compared between the Exercise and Education groups using generalized regression for repeated measures on each of the test results from baseline to discharge to 12 weeks post-discharge
Measured: 12-week follow-up period
Brain-Imaging Data
To examine pre- to post-intervention differences in D2/D3 receptor availability a repeated-measures ANOVA will be performed using the binding potential for [18F]fallypride in subcortical regions of interest.
Measured: End of intervention (9 weeks)
Psychiatric Symptoms
The effect of the interventions will be compared with repeated measures analysis from baseline to discharge to 12 and 26 weeks after discharge.
Measured: 12 week follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for AddictionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Richard Rawson, University of California, Los Angeles
- Investigators
- Richard Rawson, PhD, Principal investigator, UCLA Integrated Substance Abuse Programs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103531
- Sponsor's protocol ID
- 09-08-099
- Other IDs
- 1R01DA027633
- Status last verified
- Nov 2015
- First submitted
- 31 Mar 2010
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cooper CB. Exercise in chronic pulmonary disease: aerobic exercise prescription. Med Sci Sports Exerc. 2001 Jul;33(7 Suppl):S671-9. doi: 10.1097/00005768-200107001-00005.
PubMed 11462076Fonkalsrud EW, Mendoza J, Finn PJ, Cooper CB. Recent experience with open repair of pectus excavatum with minimal cartilage resection. Arch Surg. 2006 Aug;141(8):823-9. doi: 10.1001/archsurg.141.8.823.
PubMed 16927491Glasner-Edwards S, Mooney LJ, Marinelli-Casey P, Hillhouse M, Ang A, Rawson R; Methamphetamine Treatment Project Corporate Authors. Clinical course and outcomes of methamphetamine-dependent adults with psychosis. J Subst Abuse Treat. 2008 Dec;35(4):445-50. doi: 10.1016/j.jsat.2007.12.004. Epub 2008 Feb 21.
PubMed 18294802Glasner-Edwards S, Mooney LJ, Marinelli-Casey P, Hillhouse M, Ang A, Rawson R; Methamphetamine Treatment Project. Identifying methamphetamine users at risk for major depressive disorder: findings from the methamphetamine treatment project at three-year follow-up. Am J Addict. 2008 Mar-Apr;17(2):99-102. doi: 10.1080/10550490701861110.
PubMed 18393051Glasner-Edwards S, Mooney LJ, Marinelli-Casey P, Hillhouse M, Ang A, Rawson R; Methamphetamine Treatment Project. Risk factors for suicide attempts in methamphetamine-dependent patients. Am J Addict. 2008 Jan-Feb;17(1):24-7. doi: 10.1080/10550490701756070.
PubMed 18214719Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1423-34. doi: 10.1249/mss.0b013e3180616b27.
PubMed 17762377Lautenschlager NT, Cox KL, Flicker L, Foster JK, van Bockxmeer FM, Xiao J, Greenop KR, Almeida OP. Effect of physical activity on cognitive function in older adults at risk for Alzheimer disease: a randomized trial. JAMA. 2008 Sep 3;300(9):1027-37. doi: 10.1001/jama.300.9.1027.
PubMed 18768414Malek MH, Fonkalsrud EW, Cooper CB. Ventilatory and cardiovascular responses to exercise in patients with pectus excavatum. Chest. 2003 Sep;124(3):870-82. doi: 10.1378/chest.124.3.870.
PubMed 12970011Monterosso JR, Ainslie G, Xu J, Cordova X, Domier CP, London ED. Frontoparietal cortical activity of methamphetamine-dependent and comparison subjects performing a delay discounting task. Hum Brain Mapp. 2007 May;28(5):383-93. doi: 10.1002/hbm.20281.
PubMed 16944492Palmer JA, Palmer LK, Michiels K, Thigpen B. Effects of type of exercise on depression in recovering substance abusers. Percept Mot Skills. 1995 Apr;80(2):523-30. doi: 10.2466/pms.1995.80.2.523.
PubMed 7675585Rawson RA, Anglin MD, Ling W. Will the methamphetamine problem go away? J Addict Dis. 2002;21(1):5-19. doi: 10.1300/j069v21n01_02.
PubMed 11831500Rawson RA, Marinelli-Casey P, Anglin MD, Dickow A, Frazier Y, Gallagher C, Galloway GP, Herrell J, Huber A, McCann MJ, Obert J, Pennell S, Reiber C, Vandersloot D, Zweben J; Methamphetamine Treatment Project Corporate Authors. A multi-site comparison of psychosocial approaches for the treatment of methamphetamine dependence. Addiction. 2004 Jun;99(6):708-17. doi: 10.1111/j.1360-0443.2004.00707.x.
PubMed 15139869Simon SL, Domier C, Carnell J, Brethen P, Rawson R, Ling W. Cognitive impairment in individuals currently using methamphetamine. Am J Addict. 2000 Summer;9(3):222-31. doi: 10.1080/10550490050148053.
PubMed 11000918Simon SL, Domier CP, Sim T, Richardson K, Rawson RA, Ling W. Cognitive performance of current methamphetamine and cocaine abusers. J Addict Dis. 2002;21(1):61-74. doi: 10.1300/j069v21n01_06.
PubMed 11831501Skrede A, Munkvold H, Watne O, Martinsen EW. [Exercise contacts in the treatment of substance dependence and mental disorders]. Tidsskr Nor Laegeforen. 2006 Aug 10;126(15):1925-7. Norwegian.
PubMed 16915316
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Exercise to Improve Outcomes of Treatment for Methamphetamine Dependence
- ClinicalTrials.gov ID
- NCT01103531
- Acronym / sponsor ID
- 09-08-099
- Conditions
- Addiction
- Keywords
- Methamphetamine, Methamphetamine Dependence, Methamphetamine Treatment, Aerobic Exercise, Resistance Exercise, Brain Imaging, D2 and D3 receptor availability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2010
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 14 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effects of an aerobic and strength training exercise program (one that increases the need for oxygen and increases muscle) on the treatment outcomes of 150 individuals in treatment for methamphetamine dependence at Cri-Help. The study will determine if a 60-minute exercise program (three times a week) has an effect (good or bad) on the health and drug use of participants as compared to individuals not participating in an exercise program.
Detailed description
Participants were recruited to the study using various methods, including word of mouth and IRB-approved flyers posted throughout the treatment facility. Onsite study staff screened MA-dependent clients in a private study office and reviewed the informed consent protocol. After completion of informed consent procedures, participants entered a1-2week screening phase to determine eligibility, consisting of medical history, physical exam, laboratory studies, and ECG. Eligible clients were taken through study baseline assessments to inform randomization to study conditions, either an exercise intervention or health education control, using a computerized urn randomization program that stratified clients to conditions based on gender (male/female) and severity of baseline MA use (higher vs. lower severity). The cut-off point for determining lower severity MA use versus higher severity use was identified using data from previous clinical outcome studies that show the median number of days of MA use ranges from16 to 20 days at treatment entry. Hence, we defined "lower severity" as using MA for 18 or fewer days in the previous month, and "higher severity" as using for 19 or more days in the past month. The study's data management center (DMC) maintained the urn randomization program and the records that linked participant identification numbers to study condition. Study interventions were conducted onsite while participants were enrolled in usual care at the residential treatment facility; cases of early discharge from the facility resulted in premature termination from the study.
Participants randomized to the exercise condition received a structured exercise program 3 times a week for 8 weeks. Exercise sessions consisted of a 5-min warm-up, 30 min of aerobic activity on a treadmill, followed by 15 min of weight training and a 5-min cool-down/stretching period. Each session was monitored by a staff exercise physiologist who guided one to two participants at a time. Using heart rate monitors, the exercise physiologist worked closely with each individual participant on exercise days to increase treadmill speed/slope to maintain a heart rate between 60% and 85% of maximum for 30 minutes. Once a participant was able to complete two sets of 15 repetitions of any given exercise, weight was incrementally increased.
A data collection protocol occurred at baseline, and also weekly during the 8-week study period, at termination of the study period, and at 1-, 3-, and 6-months post treatment from the residential program (approximately 7-10 days following completion of the intervention period). Participants were compensated $40 per data collection session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Behavioral: Aerobic and Resistance ExerciseParticipants in this group will be scheduled for 24 exercise training sessions over an 8-week period (three times weekly) and will be supervised by a certified exercise physiologist. |
| Education Group | Active comparator | Behavioral: Educational information about health topicsParticipants in this group will meet with a counselor who will present and discuss information that includes topics on health and wellness, and lifestyle topics such as healthy eating, meditation, sleep hygiene, and cancer screening. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Be seeking treatment for their MA dependence;
- Be 18 years of age or older, and 45 or younger for males, 55 or younger for females;
- Meet DSM-IV-TR criteria for MA dependence;
- Have vital signs that are within clinically acceptable normal range, e.g., resting pulse between 50 and 90 /min, blood pressures between 85-150mm Hg systolic and 45-90mm Hg diastolic;
- Have a medical history and physical examination that, in the judgment of the study physician or Principal Investigator, show no clinically significant contraindications for study participation;
Key exclusion criteria (9 listed)
- Clinically significant heart disease or hypertension; unstable pulmonary or cardiovascular disease that would interfere with participation in exercise regimen
- Neurological or psychiatric disorders as assessed by MINI or clinical interview, such as psychosis, bipolar illness, Tourette's syndrome, major depression, organic brain disease, dementia, or any other neuro-psychiatric disorder that would require ongoing treatment or that would make study compliance difficult;
- Musculoskeletal disease that would prevent participation in exercise regimen
- Baseline ECG showing evidence of cardiac ischemia, arrhythmia, or other clinically significant abnormalities
- Untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease (other than HIV) that requires immediate medical attention;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic and Resistance ExerciseAerobic and resistance exercise for 24 exercise training sessions over an 8-week period (three times weekly). | Behavioural | Exercise Group |
| Educational information about health topicsA counselor will meet with participants for 24 sessions (3 times/week) over an 8-week period to present and discuss information that includes topics on health and wellness, and lifestyle topics such as healthy eating, meditation, sleep hygiene, and cancer screening. | Behavioural | Education Group |
Primary outcome
Self-reported Days of Methamphetamine Use
Time frame: over the 12 week follow-up period
The primary efficacy measure will be days of self-reported MA use over the 12 weeks after discharge.
3 secondary outcomes
Overall Physical Health
Time frame: 12-week follow-up period
Brain-Imaging Data
Time frame: End of intervention (9 weeks)
Psychiatric Symptoms
Time frame: 12 week follow-up period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Background: PubMed 11462076Cooper CB. Exercise in chronic pulmonary disease: aerobic exercise prescription. Med Sci Sports Exerc. 2001 Jul;33(7 Suppl):S671-9. doi: 10.1097/00005768-200107001-00005.
- Background: PubMed 16927491Fonkalsrud EW, Mendoza J, Finn PJ, Cooper CB. Recent experience with open repair of pectus excavatum with minimal cartilage resection. Arch Surg. 2006 Aug;141(8):823-9. doi: 10.1001/archsurg.141.8.823.
- Background: PubMed 18294802Glasner-Edwards S, Mooney LJ, Marinelli-Casey P, Hillhouse M, Ang A, Rawson R; Methamphetamine Treatment Project Corporate Authors. Clinical course and outcomes of methamphetamine-dependent adults with psychosis. J Subst Abuse Treat. 2008 Dec;35(4):445-50. doi: 10.1016/j.jsat.2007.12.004. Epub 2008 Feb 21.
- Background: PubMed 18393051Glasner-Edwards S, Mooney LJ, Marinelli-Casey P, Hillhouse M, Ang A, Rawson R; Methamphetamine Treatment Project. Identifying methamphetamine users at risk for major depressive disorder: findings from the methamphetamine treatment project at three-year follow-up. Am J Addict. 2008 Mar-Apr;17(2):99-102. doi: 10.1080/10550490701861110.
- Background: PubMed 18214719Glasner-Edwards S, Mooney LJ, Marinelli-Casey P, Hillhouse M, Ang A, Rawson R; Methamphetamine Treatment Project. Risk factors for suicide attempts in methamphetamine-dependent patients. Am J Addict. 2008 Jan-Feb;17(1):24-7. doi: 10.1080/10550490701756070.
- Background: PubMed 17762377Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1423-34. doi: 10.1249/mss.0b013e3180616b27.
- Background: PubMed 18768414Lautenschlager NT, Cox KL, Flicker L, Foster JK, van Bockxmeer FM, Xiao J, Greenop KR, Almeida OP. Effect of physical activity on cognitive function in older adults at risk for Alzheimer disease: a randomized trial. JAMA. 2008 Sep 3;300(9):1027-37. doi: 10.1001/jama.300.9.1027.
- Background: PubMed 12970011Malek MH, Fonkalsrud EW, Cooper CB. Ventilatory and cardiovascular responses to exercise in patients with pectus excavatum. Chest. 2003 Sep;124(3):870-82. doi: 10.1378/chest.124.3.870.
- Background: PubMed 16944492Monterosso JR, Ainslie G, Xu J, Cordova X, Domier CP, London ED. Frontoparietal cortical activity of methamphetamine-dependent and comparison subjects performing a delay discounting task. Hum Brain Mapp. 2007 May;28(5):383-93. doi: 10.1002/hbm.20281.
- Background: PubMed 7675585Palmer JA, Palmer LK, Michiels K, Thigpen B. Effects of type of exercise on depression in recovering substance abusers. Percept Mot Skills. 1995 Apr;80(2):523-30. doi: 10.2466/pms.1995.80.2.523.
- Background: PubMed 11831500Rawson RA, Anglin MD, Ling W. Will the methamphetamine problem go away? J Addict Dis. 2002;21(1):5-19. doi: 10.1300/j069v21n01_02.
- Background: PubMed 15139869Rawson RA, Marinelli-Casey P, Anglin MD, Dickow A, Frazier Y, Gallagher C, Galloway GP, Herrell J, Huber A, McCann MJ, Obert J, Pennell S, Reiber C, Vandersloot D, Zweben J; Methamphetamine Treatment Project Corporate Authors. A multi-site comparison of psychosocial approaches for the treatment of methamphetamine dependence. Addiction. 2004 Jun;99(6):708-17. doi: 10.1111/j.1360-0443.2004.00707.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Rawson, PhD principal investigator
UCLA Integrated Substance Abuse Programs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic and Resistance Exercise and Educational information about health topics in people with Addiction, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported Days of Methamphetamine Use (time frame: over the 12 week follow-up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01103531, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.